FDA Registration
Active
🇺🇸 United States
SENZIME INC.
Reg #: 3016560306
·
FEI: 3016560306
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- SENZIME INC.
- Registration Number
- 3016560306
- FEI Number
- 3016560306
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 748 Hanley Industrial Ct.
- City
- Saint Louis
- State
- MO
- ZIP
- 63144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250977
Owner / Operator
- Firm Name
- Senzime Inc. Respiratory Motion
- Operator Number
- 10062654
- Address
- 748 Hanley Industrial Court
- City
- Saint Louis
- State
- MO
- Postal Code
- 63144
- Country
- US
- Correspondent
- George Hamilton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2026-01-19 |
Proprietary Names
Suturion
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility